The Alinity m System recall
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Why was The Alinity m System recalled?
Incorrect optical calibration
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Number 00654
- Product
- The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- 1
- Distribution
- There was only foreign distribution to Italy.
- Recall date
- August 24, 2022
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)